Tag Archives: innovation

Collaboration For Sustainable Excellence – The Name of The Game in The New Normal

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The union minister of health and family welfare of India recently invited Japanese companies to collaborate with Indian companies on research and innovation in emerging therapies, like precision medicine, cell and gene therapy, biological products, and on the utilization of digital tools and technologies. This was reported on May 16, 2023.

Underscoring this objective, the minister articulated, “such collaboration on research and innovation would help enhance the domestic availability and affordability of these innovative therapeutic options.”

The area of research and drug innovation in emerging therapies and on the utilization of digital tools and technologies has emerged as one of the top focus areas of the country in the new normal. Currently, the Indian pharmaceutical industry is primarily focused on manufacturing generic medicines, exporting bulk drugs, and supplying active pharmaceutical ingredients.

Thus, this goal can be quickly achieved through global collaborations – at a time when India plays a pivotal role in improving health outcomes worldwide by serving as a dependable supplier of affordable and high-quality generic drugs. The country is currently providing approximately 60 per cent of the global vaccine supply, and 20-22 per cent of generic exports. Importantly, ‘In the battle against the Covid-19 pandemic, India has supplied essential drugs to around 185 countries,” he underscored.

Interestingly, after the Covid-19 pandemic, there has been a significant shift in the approach of both Indian and multinational drug companies towards business collaboration. This article will focus on this area with recent Indian examples, culled from available reports. However, before delving into this space, let me also point out that drug MNCs operating in India are also changing focus on their India operations, as reported in recent times.

Drug MNCs operating in India are also changing business focus: 

This was brought to the fore by several recent reports. For example, in February 2022, The Economic Times reported: 

  • In February, Novartis India passed on the sales and distribution rights of three of its established brands to Dr Reddy’s Labs and terminated the employment of 400 staffers.  
  • In October, US drugmaker Eli Lilly sold the marketing rights of its anti-diabetes drugs to Cipla and laid off 120 employees in India. 
  • Around the same time, Danish pharma company Lundbeck decided to exit India as part of its global strategy. 

However, their key goal remains - delivering new patient-perceived value – not just incremental, but in quantum measure for business growth.

The need for increased collaboration and shared resources:

Against the above backdrop, it appears to me that the pandemic has highlighted the need for accelerated cooperation and sharing resources to address global healthcare challenges, effectively. As a result of which, both Indian and MNC drug companies are recognizing the benefits of working together, and are actively seeking collaboration opportunities in the following areas. 
  • Access to Emerging Markets: Indian pharma companies have a strong presence in emerging markets due to their cost-effective generic drug manufacturing capabilities. Multinational companies recognize the potential of these markets and are looking to collaborate with Indian firms to gain access to these regions. By partnering with Indian companies, MNCs can tap into local expertise, distribution networks, and regulatory knowledge. 

- Example: In 2022, Cadila Healthcare entered into a collaboration with Novartis to develop and commercialize multiple oral solids and injectable generics for global markets, including emerging markets.

  • Research and Development: Collaboration in research and development (R&D) activities has become crucial for drug companies. MNCs bring advanced research capabilities, cutting-edge technologies, and substantial financial resources, while Indian companies offer a skilled workforce and a cost-effective environment for R&D. By joining forces, they can pool their strengths and accelerate the discovery and development of new drugs and therapies.

- Example: In 2021, Bharat Biotech collaborated with the Washington University School of Medicine in St. Louis and the International AIDS Vaccine Initiative (IAVI) to develop a novel vaccine candidate for HIV. This collaboration aims to combine the strengths of all three organizations to advance HIV vaccine research.

  • Manufacturing and Supply Chain: The pandemic exposed vulnerabilities in global supply chains, particularly in the pharmaceutical sector. Collaborations between Indian and MNC drug companies can help diversify manufacturing locations and strengthen supply chain resilience. Indian companies’ expertise in large-scale generic drug production can complement the specialized manufacturing capabilities of multinational firms.

- Example: In 2021, Hetero entered into a partnership with the Russian Direct Investment Fund (RDIF) to manufacture the Sputnik V Covid-19 vaccine in India. This collaboration aimed to increase the production capacity of the vaccine to meet global demand.

  • Regulatory Compliance: Regulatory compliance is a critical aspect of the pharmaceutical industry. Indian companies have been working closely with regulatory authorities to meet global standards and gain approvals for their products. Collaborating with Indian companies enables MNCs to leverage their understanding of regulatory processes, navigate local regulations efficiently, and ensure compliance with diverse international requirements.

- Example, in 2022, Biocon Biologics partnered with Adagio Therapeutics, a US-based biotechnology company, to develop and commercialize an antibody treatment for COVID-19. This collaboration involves regulatory support from both companies to navigate global regulatory processes.

  • Market Expansion: Collaborations provide an opportunity for both Indian and multinational companies to expand their market presence. Indian companies can benefit from the MNCs’ established marketing networks, while MNCs can leverage the Indian companies’ extensive distribution channels and market knowledge. Joint ventures and partnerships facilitate market entry, improve market penetration, and help companies capture a larger share of the global pharmaceutical market. 

- Example: In 2022, Torrent Pharmaceuticals collaborated with Swedish multinational company Handicare Group AB to distribute and market Handicare’s range of mobility solutions in India. This collaboration enables Torrent Pharmaceuticals to diversify its product portfolio and expand into the healthcare mobility market. 

  • Technology and Innovation Sharing: Collaborations foster knowledge exchange between Indian and multinational drug companies. MNCs can share their technological advancements and research findings, while Indian companies can contribute their insights and expertise in managing large-scale production. Such knowledge-sharing initiatives can drive innovation, improve manufacturing processes, and enhance overall operational efficiency. 

- Example: In 2022, Glenmark Pharmaceuticals entered into a collaboration with the Canadian multinational company SaNOtize Research and Development Corp. to develop a nitric oxide nasal spray for the treatment of COVID-19. This collaboration combines Glenmark’s expertise in drug development with SaNOtize’s innovative nitric oxide platform.

  • Intellectual Property and Licensing: Collaboration often involves the exchange of intellectual property (IP) rights and licensing agreements. Indian companies possess a vast pool of generic drug formulations and manufacturing capabilities. MNCs can license their patented drugs or technology to Indian partners for production and distribution in specific markets. These licensing arrangements benefit both parties by expanding the product portfolio and maximizing revenue potential. 

- Example: In 2021, Glenmark Pharmaceuticals signed a licensing agreement with Canadian biopharmaceutical company Xenon Pharmaceuticals to develop and commercialize a potential treatment for epilepsy. This collaboration involves the licensing of Xenon Pharmaceuticals’ proprietary technology for the development of a novel therapeutic product.

Conclusion:

Overall, as the recent trends indicate, the post-pandemic era has accelerated initiatives of strategic collaboration between Indian and multinational drug companies. By leveraging each other’s strengths and with shared value and resources, these collaborations aim to drive innovation, address global healthcare challenges, and deliver affordable and accessible healthcare solutions to patients worldwide. And thereby, will help deliver a unique patient experience.

Additionally, the examples, as available from published sources, highlight an increasing number of such recent collaborations, besides operational re-focusing by several MNC drug majors in India.  

These strategic steps clearly emphasize their joint efforts to drive innovation, expand their market presence, and address critical healthcare needs. From this angle, I believe, for sustainable business excellence and for staying relevant to customers in the new digital world, one of the top focus areas for Indian pharma players deserves to be strategic collaboration initiatives.

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Impact of The Cost of Pharma Marketing Failure On Patients

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‘About half of all products launched over the past 15 years have underperformed pre-launch consensus forecasts by more than 20%.’ It’s one of the findings of a recent study by L.E.K. Consulting, going back to 2004. This number is besides the cost of failure while discovering a successful New Molecular Entity.

Adding this to the cost of the product innovation and development, clinical trials and other regulatory expenses, the wasteful expenditure becomes mind boggling – for any unsatisfactory launch performance. In such a situation, the probability of creating newer blockbuster therapies is not getting any easier.

As is believed by many – and vindicated by several studies, new drug marketing cost is more than its R&D cost. Which is why, ensuring success of a new drug launch is critical to fund new drug innovation – on an ongoing basis. Consequently, leadership focus on high ‘launch success’ rate is so important – as the good old saying goes – ‘well begun half done.’

In addition, prudent optimization of the success rate of new products may also help the company avoid irresponsible pricing, while improving the profit margin. In this article, I shall deliberate on the impact of the cost of marketing failure on patients, in general. Alongside, the avoidable ‘soft ground’ that marketers may wish to avoid while delivering unmet value to patients.

Big Pharma’s Sales and Marketing spend is more than R&D:

According to another recent study of October 27, 2021, ‘in most cases, more of the dollars spent by drug manufacturers go toward selling and marketing costs than toward research and development (R&D) for new treatments, cures, or expanded indications and uses of existing drugs.’ For example, as the paper highlights:

  • AbbVie, which manufactures branded drugs like Humira, spent $11 billion in sales and marketing in 2020, compared with $8 billion on R&D.
  • Bayer, which manufactures branded drugs like Xarelto (codeveloped with Johnson & Johnson) and Eylea, spent $18 billion in sales and marketing, compared to $8 billion on R&D.
  • Johnson & Johnson, which manufactures branded drugs like Xarelto (codeveloped with Bayer) and Stelara, spent $22 billion on sales and marketing, compared to $12 billion on research and development.

Therefore, just as R&D expenses have to be made more productive, so are the sales & marketing expenses, where the expenditure towards new product launches is a critical component.

Why a successful new product launch is important:

An analysis by Deloitte in this area, published on March 26, 2020, found that most new drugs continue with the revenue trajectory set at launch. It said, about 70 percent of products that miss expectations at launch continue doing so in subsequent years, and around 80 percent of products that meet or beat expectations continue to do so afterward. Thus, launch success of a new product is very important, both for the organizations and the patients.

A successful new product launch helps both the company and patients:

Correctly assessing and leveraging full commercial potential of a new product through its effective launch helps both the patients and the company. This subject was discussed in a recent article, published in the Fierce Pharma on October 25, 2021, in the context of many drug launch disasters. The areas of benefits, I reckon, include the following:

  • Patients’ unmet needs are met at a reasonable price
  • Manufacturer can recoup its research and development costs.
  • Fund future drug discoveries.
  • Satisfy investors with handsome returns.
  • Creating a sound brand performance base – as a strong launch is arguably the most critical step in a new drug’s lifecycle.

New product launch failure is across the disease areas – from Big Pharma to Startups:

As the above December 18, 2020, study by L.E.K. Consulting points out that new products’ launch failure is taking place across the disease areas. These include,  Oncology, immunology, infectious disease, ophthalmology, blood disorders, brain diseases, and cardiovascular and metabolic disease. Similarly, the companies responsible for such failure span across global pharma majors to biotech startups.

Why many companies are failing in this process:

To help ascertain the depth of this issue, let me start with the key objective of a new product launch, which is effectively delivering the holistic value of the brand which consumers would appreciate. Several papers also acknowledge, to succeed in this area, pharma players need to prepare their data-based launch plan with cerebral power and ensure that the strategy is working and is being executed flawlessly.

A large number of studies find, ‘many companies fail in this process, due to a combination of factors.’ Some of these are uncontrollable, but many of which are very much within a marketer’s control.

Examples of uncontrollable and controllable variables:

Uncontrollable factors include post marketing approval drug safety issues. Reports indicate, ‘One-Third Of New Drugs Had Safety Problems After FDA Approval.’ This is being reported even in recent times, like, ‘new safety signals that cropped up after the approvals of Novartis’ eye drug Beovu  and Sanofi’s dengue vaccine Dengvaxia.’

Whereas, controllable factors include, poor product differentiation and other management missteps, besides ‘limited market access, poor understanding of market needs or misjudgment of competitive threats.’ For example, poor product differentiation and other management missteps were, reportedly, ‘the cause of trouble for Clovis Oncology’s Rubraca in the PARP inhibitor space, and Merck & Co. and Pfizer’s Steglatro in the SGLT2 field.

Key success ingredients to focus on:

Since long, various research, including one by Bain & Co dated October 2017, has highlighted that over 50% of new product launches are underperforming. This situation can’t, in any way, be accepted as a ‘thumb rule’ by pharma marketers, any longer.  Mainly because: ‘When a drug misses its launch projections, there’s a high likelihood that it will never recover that revenue,’ as their study findings underscore. From this perspective, listed below are some of the basic areas to focus on for greater launch success, as I have experienced:

  • Early launch planning – well before the regulatory approval for new products.
  • Data-based and well-tested target-audience identification, the target markets’ selection and key opinion leaders need to be selected for greater focus in effective stakeholder engagement.
  • Creating differentiated value-propositions that addresses targeted patients’ unmet needs, and, in tandem, offers scope for commensurate premium pricing, are vital.
  • Product pricing should be based on quality of value delivery to patients that they can perceive and would acknowledge. Misvaluing a brand, and just focusing on those who can pay, may attract negative publicity, creating a key barrier to success.
  • Current competition, their ongoing counter strategy, new market competitors and other launch challenges need to be carefully mapped, for strategic fine tuning or course correction, in time, wherever and whenever needed.
  • Execution of the launch plan must be accomplished with military precision, as it were.

Conclusion:

As the above Bain & Co paper articulated, ‘The most consistently undervalued factor contributing to a successful launch is the way leadership teams organize and the manage the launch process.’

It’s again not too difficult to understand that the net accountability of the cost of marketing failure, which is a major contributing factor to stifle the R&D funding, in many cases, squarely falls on pharma leadership.

Instead of taking corrective action in this critical area, most of them choose the easy path – increase new product pricing to achieve targeted revenue from a smaller unit sale of the brand. The net impact of which is on patients due to access barrier caused by high prices.

Such products, without clearly differentiated value propositions that patients would recognize, would further increase sales and marketing costs, and could even result in marketing malpractices. Under this backdrop, serious and thoughtful attempt in making all new product launches successful money spinners, as respective brands will merit, may help the pharma leadership to create a win-win situation for both the company and patients.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Big Pharma Fails Avoiding Drug Price ‘Control’? Even In The US? Why?

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It ultimately happened – even in the United States, as the US President signed a bill on August 16, 2022 that aims to reduce healthcare costs, alongside fighting climate change, besides raising taxes on the rich. This new law was enacted, despite powerful lobbying and the vehement opposition of big pharma associations and that too in their home turf.

According to the Fierce Pharma report of the same day, since the current US President moved into the White House in 2020, the drug industry left no stone unturned battling to preserve pricing status-quo. It further added, the ‘pharmaceutical industry, including, PhRMA, its allies, and the nation’s largest pharmaceutical firms’ have spent more than $205 million in multi-media ads opposing ‘Medicare price negotiations’ and lobbying against efforts to lower drug prices for consumers.’

No wonder, when the bill was just introduced to the US lawmakers, big pharma’s disappointment on the bill was palpable. This gets well-captured in what the AbbVie CEO pointed out at that time. He said, ‘the legislation would force manufacturers to accept the government’s proposed price or face a harsh tax on their revenues from a given product.’ He also said: “So, it’s not a negotiation,” as stated in the bill. He further opined in his conference call: “We should just call it what it is. It’s price controls,’ which is what the lawmakers are ‘basically putting in place, if the language stays the same,’ the AbbVie chief added.

Capturing this new development in the United States, at least, in the recent past - Fierce Pharma in its August 08, 2022, issue commented: “The seemingly unstoppable pharma lobbying force has lost its charm. With the passage of a new bill, the U.S. Senate is opening the door to major drug pricing reform, leaving the drug industry licking its wounds.”

In the Eldorado of the global drug industry, this is indeed an unprecedented initiative to significantly reduce costs of many important drugs and reduce patients’ out of pocket expenses. Consequently, it has created so much of hullabaloo, across the world, for various reasons. In this article, I shall track this emerging scenario along with the message that it sends across the globe, and its possible impact on new drug innovation to meet unmet needs of patients. In India, one such area could be revisiting the price negotiation proposal for patented drugs, a government initiative that failed to take off earlier.

Would lowering prices stifle new drug innovation?

The apprehension, I reckon, that big pharma will continue to play with - price control will stifle new product innovation – adversely impacting patient interest. Notably, to many industry experts, this argument doesn’t just lack robustness, seems more a conjecture rather than the outcome of any peer- reviewed research study findings. On ewthe contrary, several highly credible and independent studies prove otherwise. Thus, let me put hereunder:

  • One – what big pharma directly and through their powerful industry associations or some financially sponsored studies are saying
  • And – what the top experts concluded from their independent analysis in this regard, as published in the globally acclaimed journals.

I leave it to my readers to evaluate the credibility of each to form their views.

Drug industry arguments supported by recent studies:

The findings of a study conducted recently, with the financial support of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), Amgen, Pfizer, Alexion, AbbVie, Genentech, and Bristol Myers Squibb, were released by PhRMA on November 23, 2021. The study was conducted by Vital Transformation. The key findings of this study highlighted: ‘Every 10% drop in the price of medicines in price-controlled EU markets was associated with a:

  • 14% decrease in total VC funding (10% early stage and 17% late stage)
  • 7% decrease in biotech patents
  • 9% decrease in biotech start-up funding relative to the US
  • An 8% increase in the delay of access to medicines.

It concluded: ‘Drug pricing controls implemented in the US would likely have an even greater impact on Biopharma KPIs given its global leadership in investment and innovation.’

Independent expert studies, published in highly reputed journals:

Around the same time as the above report, an independent study published in the Harvard Business Review (HBR) on October 01, 2021, found exactly the opposite. It categorically stated: ‘The U.S. can lower drug prices without sacrificing innovation.’

The paper summed up: ‘With Congress considering legislation to allow Medicare to use its bargaining power to negotiate lower drug prices, large pharmaceutical companies are once again waging a campaign that contends that doing so would seriously harm the development of breakthrough drugs. This is not true. Smaller companies now account for the lion’s share of such breakthroughs. The key to supporting drug innovation is to increase NIH funding of the efforts that give rise to these new companies, cut the costs, and accelerate the speed of clinical trials, and reform patent law.’

Drug pricing in the Indian context:

Prices of, especially, new drugs and the overall cost of healthcare are two major concerns – more in the developing countries like India. Responding to this need drug price control for pre-defined essential medicines are already in place in the country. More recent studies further vindicate the relevance of such regulation from the perspective of affordability of drugs for the poorer section of the society, and where out of pocket expenses are very high.

Let me quote one such paper, published on June 04, 2022, which received no outside financial support from this study, where the researchers concluded: ‘With induced demand and an inadequate competitive environment, the pharmaceutical industry fails to reduce prices. Supply-chain trade margins are very high. Hence, government intervention through price control of essential and life-saving drugs is a necessity in India.’

In this context, another question that is being raised – are there other alternatives to expand access to high-priced life-saving drugs at an affordable cost to all those who need those most? The most common alternative that floats, encourage more competition for those drugs as soon as they go off patent. Let me examine what’s big pharma players are doing in that area.

Does Big Pharma encourage increasing competition to reduce drug prices?

Another way to reduce the price of an expensive product is encouraging competition to enable market forces bring down the price. An interesting article on breaking the rule of drug pricing by pharma companies was published in the Forbes magazine on June 29, 2022. I also wrote on June 10, 2013: ‘To scale-up access to health care, especially for the marginalized population of any country, greater access to affordable generic drugs will always remain fundamental, besides improving healthcare infrastructure and its delivery mechanism.’

Thus, there should be a robust mechanism, across the world, to facilitate quick entry of cheaper generic equivalents immediately after patent expiry of the original molecule. Increasing attempts of blocking entry of generics surreptitiously by vested interests, leaves no other alternative, but price control. This is imperative, ‘as without the availability of newer generics, unmet medical needs of the most vulnerable section of the society cannot be met effectively by any country, as I wrote there.

Attempts to game the system to minimize competition continue unabated:

Even after my article, this red flag is being raised for quite some time. It will be evident from another Harvard Business Review article titled, ‘How Pharma Companies Game the System to Keep Drugs Expensive,’ published in the on April 06, 2017. Acknowledging: ‘Drug development is risky and expensive, thanks to the long testing and approval process,’ the author concluded from their study – ‘But, increasingly, makers of branded drugs are using a variety of tactics to extend their exclusive rights,’ enabling them to maintain high drug prices for much longer time.

More recently, the above Forbes article of June 10, 2022 also highlighted, ‘even the most generous patent protections come to an end and companies must face the potential for generic competition. That’s when major drug manufacturers shift tactics from influencing policy to crushing the competition.’ There are several legal and semi-legal approaches that big pharma players adapt to game the system and maintain pricing monopoly. Let’s recap it with just three of these examples:

- ‘Patent Thicket: Delaying entry of lower price off-patent molecule through a Patent Thicket. This involves creation of ‘a dense web of overlapping intellectual property rights that a generic pharma company must hack its way through in order to actually commercialize new technology of a drug molecule,’ even after the original patent expires. For example, AbbVie’s Humira, the world’s best-selling drug for a long time. I also discussed this issue in my blog over three years ago – on April 22, 2019.

- ‘Pay-for-delay deals’:  I discussed this issue in this blog on June 19, 2013. Moreover, the above Forbes article of June 29, 2022, also underscored this tactic. It explained that this is a deal in which drug companies agree not to compete for a set amount of time to maintain high prices of their brand-name drugs. The article, published in Bloomberg Law on February 20, 2020, captures it nicely.

- Authorized generics: As many would know, law permits six months of exclusivity to the first generic version of an off-patent new molecule coming into the market. Interestingly, just before patent expiry of an innovative drug, several drug makers roll out their own generics to stifle competition. Although, they keep different names for the generic versions, but pricing remains almost similar. Such a practice obliviously delays the entry of cheaper generics, at least by six months.

In this scenario, the new drug prices continue racing north. Something was to be surely done – for patients’ sake, as many believe, at least, where it all started – the US.

New drug prices are highest in 2022:

As reported by Reuters on August 16, 2022:

  • Eight of 13 drugs launched in 2022 priced over $200,000 per year
  • Median annual price for new U.S. drugs this year is $257,000
  • Some drugmakers disclose less information on pricing

Despite this, as reported on August 15, 2022: ‘The main U.S. drug lobby has said it will push back against the legislation, which includes policies that drug makers have opposed for decades.’

Conclusion:

The significance of the above development in the US healthcare scenario, was aptly summed-up by the US House Speaker, as she said: “If you are sitting at your kitchen table and wonder how you’re going to pay the bills – your health care bills, your prescription drug bills – this bill is for you.” For the first time in the US – the champion of champions of free-drug pricing market, will negotiate the drug price with their manufacturers to become patient -centric.

The reverberations of this difficult decision, especially on new drug prices, are expected to prompt the need for price negotiation or price control, primarily for expanding access to new drugs for a larger number of patients. This deserves to be a focus area for the Government, including India. Moreover, the August 18, 2022, media report also suggests that the top court of India may now encourage the Government to investigate, report and take remedial action on drug industry malpractices.

Finally, it’s worth noting that over a decade ago, international media widely reported -  ‘India considering price controls for patented drugs.’ Its objective was to address the aggressive new drug pricing trend in the country. Accordingly, the price negotiation proposal for patented drugs was notified by the Department of Pharmaceuticals (DoP) in 2007. The constituted Committee submitted a report, as well, on February 21, 2013. But it did not take off as on date. Many apprehend, this is due to intensive and ongoing lobbying by big pharma, just as what happened in the US. Nevertheless, the question that surfaces – will the above new drug law in the largest pharma market in the world encourage the DoP to revisit price negotiation for patented drugs - to make modern drugs affordable to a larger patient population in India – now?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Focus On All 3 Areas of Innovation For Affordable Access To Innovative Drugs

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Medical treatment has made astonishing advances over the years. But the packaging and delivery of that treatment are often inefficient, ineffective, and consumer unfriendly. This was articulated in an article on innovation in healthcare, published in the Harvard Business Review, way back, in its May 2006 issue.

Highlighting soaring healthcare cost, including ‘out of pocket’ health expenditure, and its impact on public health, the paper recommended innovative solutions for every related aspect of health care. These encompass – healthcare delivery, unleashing the power of technology, and customer-centric business models. Interestingly, despite enormous investment in drug innovation, the access to affordable health care for all, continued over the years.

The consequential scenario was well articulated in another paper on rising consumerism among healthcare consumers, published in the Deloitte Review issue 16, 2015. It noted, the existing business models are increasingly being challenged by all concerned. The aim is to find new sources of value – as expected by patients and deliver them effectively with innovative approaches for better outcomes. This has, initiated a recalibration of the healthcare system, as it were, in many parts of the world, including many -both developed and developing countries, across the globe.

In this article, I shall try to explore this area, especially from the perspective of relevance of innovative business models for affordable access to innovative drugs in the new normal. Let me start with three basic innovation needs in the pharma business that may help chart out a meaningful pathway to attain this goal.

3 innovation areas to make health care better and cheaper:

In pharma industry, people mostly talk about product or treatment innovation. Although, this is of paramount importance to make healthcare more and more effective with time, but may not help save or heal more patients, commensurately.

Going by the ‘health care innovation catalog,’ as charted by the above Harvard Business Reviewarticle, ‘three kinds of innovation can make health care better and cheaper.’ These innovations are primarily related to:

  • Use of ‘technology’ to develop new products and treatments or to improve care
  • Bringing in innovative changes the ways ‘consumers’ buy and use healthcare.
  • Generating new ‘business models’, particularly those that involve the horizontal or vertical integration of separate health care organizations or activities.

As I have deliberated in the past, related to the first two areas, this discourse will deliberate on the third type of innovation to explore the above specified area. Let me hasten to add that several studies published in the later dates, echoed similar approach.

Subsequent studies reinforce the point:

One such example, is the paper titled ‘Innovative Approaches to Increase Access to Medicines in Developing Countries’, published in the Frontiers in Medicine on December 07, 2017. This study also captured: ‘Access to essential medicines is problematic for one third of all persons worldwide. The price of many medicines (i.e., drugs, vaccines, and diagnostics) is unaffordable to the majority of the population in need, especially in least-developed countries, but also increasingly in middle-income countries.’

The paper highlighted, several innovative approaches, based on partnerships, intellectual property, and pricing, can further stimulate innovation, promote healthcare delivery, and reduce global health disparities, significantly. It underscored: ‘No single approach suffices, and therefore stakeholders need to further engage in partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in low- and middle-income countries (LMICs) in an effort of making them available at affordable and acceptable conditions.’

Changing business model concept gaining steam during Covid pandemic:

The issue of affordable access to innovative medicines drew attention of all stakeholders, even the common man, during the Covid pandemic – more than ever before. Several publications raised a flag on this barrier to public health, especially amid a pandemic or epidemic like situation.

One of these papers, titled ‘COVID-19 and the global public health: Tiered pricing of pharmaceutical drugs as a price-reducing policy tool’, was published in the Journal of Generic Medicines, on October 07, 2020. The paper emphasized, COVID-19 has raised serious concerns about affordable and equitable access to critically needed innovative medicines and other health technologies. It pointed out: ‘Patent exclusivities add to the cost of healthcare by allowing supra-competitive prices of protected technologies’, it commented. At the same time, ‘the prices and availability of drugs also depend on certain other factors that are not related to IP protection.’

Here comes the concept of ‘differential pricing’ or ‘tiered pricing’. This is a voluntary price-reducing policy option of the innovator to sell innovative drugs at lower prices in developing countries – compared to developed nations. The study articulated, more and more innovators imbibing this option in the future, could be a way forward to address for the future. Could it be a win-win solution for this critical issue?

Is it a win-win solution to this critical issue?

Since, at least, the last decade, the concept of differential pricing or tiered pricing ‘has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to these life-saving products.’ This was also noted in the paper - ‘A critical analysis of tiered pricing to improve access to medicines in developing countries,’ published in the journal Globalization and Health, on October 12, 2011.

Even at that time, the paper said: ‘International tiered pricing has been proposed as an alternative to high prices when separable high- and low-to-middle-income markets exist for a medicine and when the seller exerts significant power over pricing, such as when there is limited or no competition due to patent protection, data exclusivity, or other market-entry barriers.’

Interestingly, despite above findings, tiered pricing has not been a widely followed concept in the old normal to ensure affordable access to life-saving innovative drugs, for all. One of its reasons could possibly be commercial considerations. Company specific business threshold of tiered pricing may not necessarily be able to offer a price that is equitable or affordable for all. That said, there are a few laudable initiatives of some major innovator companies in the past.

Some laudable past initiatives for affordable access to innovative drugs:

Since the beginning of this millennium, one can witness some laudable pricing initiatives for affordable access to critical, innovative drugs to save lives in developing countries and poorer nations. Let me give a few reported examples below:

  • Abbott Laboratories – the patent holder of lopinavir and ritonavir had initially announced a tiered price of $650 in 2001 for African countries and 16 non-African least developed countries. In 2002, the Company reduced the price to $500 for these countries and in August 2009 dropped it to $440 – slightly below the lowest generic price.
  • In 2001, Novartis offered “at-cost” tiered price of $2.40 per adult treatment course for artemether-lumefantrine FDC to WHO for developing countries After 5 years when a generic version of the same was available, Novartis decreased its tiered price to $1.80, thereafter to $1.50.
  • Eli Lilly’s two key DR-TB drugs, capreomycin and cycloserine were not widely available from other suppliers even after it went off patent. In 2002, Lilly transferred the drug manufacturing technology to several generic drug companies in TB-endemic countries. Eli Lilly’s tiered price has consistently remained below the generic prices for these drugs.

More examples of voluntary licensing during Covid pandemic:

Gilead signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture remdesivir for distribution in 127 countries that face significant obstacles to healthcare access.

Notably, the licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

On May 11, 2021, several media reports revealed that ‘US pharma giant Eli Lilly has issued royalty-free, non-exclusive voluntary licenses to three Indian drug makers – Cipla, Sun Pharmaceuticals and Lupin – to manufacture and distribute Baricitinib, which is being used to treat Covid-19.

As announced on October 27, 2021, the global drug major MSD and Medicines Patent Pool (MPP) entered into a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) including India following appropriate regulatory approvals. The Indian companies, reportedly, include, Sun Pharma, Cipla, Dr Reddy’s, Emcure Pharma and Hetero Labs.

On November 16, 2021, Pfizer Press Release stated: Pfizer and MPP has signed a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). Under the terms of the license agreement, qualified generic medicine manufacturers worldwide that are granted sub-licenses, will be able to supply this combination drug to 95 countries, covering up to approximately 53% of the world’s population.

Conclusion:

Covid Pandemic, which apparently, is refusing to vanish anytime soon, makes the issue of making affordable access to critical innovative drugs for all, more intense. Since long, researchers, academicians, practitioners, and the stakeholders involved in addressing this healthcare challenge for the majority of the population have suggested several innovative approaches.

These include, focus on three kinds of innovation simultaneously, and with similar zest, can make health care better and cheaper. One such area is changing pharma business models for critical innovative drugs. The good news is a few pharma players have already charted on this pathway in the past, successfully, by extending royalty-free, voluntary licenses to manufacturers in the developing countries and poorer nations. Some of them even tried to match their tiered pricing with equivalent generic drug prices. But the overall response was rather lukewarm in the old normal. Interestingly, the new normal signals a mindset change in this regard within a larger number of global innovators.

The current trend gives a hope to many that an increasing number of global innovators will sincerely explore – not just one, but all the three areas of innovation for affordable access to innovative drugs. This could possibly reduce, if not eliminate the future need for the grant of compulsory licenses for such drugs, as happened during the peak of Covid pandemic, especially in India.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

What Have And Haven’t Changed In Pharma’s New Normal?

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While navigating through the challenge of disruptive changes, several pharma marketers are now focusing more on creating, connecting, and leveraging all market and customer related data, across the organization. Astute ones are using state-of-the-art tools, platforms, and techniques to gain actionable insights on new demands of pharma markets. I wrote about it in my article - ‘Data: the new ‘Magic Wand’ For Pharma Business Excellence,’ published in this blog on October 01, 2018.

This process is helping them to fathom what areas the pandemic has changed and what it hasn’t. Their aim is to draw cutting-edge strategies accordingly for market effectiveness – outperforming competition. This article will explore that space with contemporary examples. Let me start with a few illustrations of some hits and misses for the treatment of Covid – as the world started learning to live with this menacing virus. This was enviable, as the requisite scientific date wasn’t readily available at that moment of truth. But the time has changed now.

Some hits and misses:

As the pandemic overwhelmed the world, and no well-documented treatment for infection caused by the brand new virus – Covid-19 was available, many drug players were given quick emergency approval by country regulators for some repurposed drugs. But most of those weren’t found effective as fresh clinical data started pouring in. For example, the World Health Organization (WHO), have, reportedly, indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.

More recently, Gilead Sciences Veklury – a failed Ebola drug, repurposed for hospitalized Covid-19 patients, suddenly became a blockbuster drug, according to a September 17, 2021 report. However, in less than a year, alongside more research data - a study from Europe, published in The Lancet Infectious Diseases, showed that Veklury has no real benefit. The report also highlights: ‘Aided by a ringing endorsement from then-president Donald Trump, Veklury rang up sales of $2.8 billion in 2020, including $1.9 billion in the final quarter. But those sales slid this year to $1.5 billion in the first quarter followed by $829 million in the second quarter.’

Similarly, there are several areas that are seemingly getting transformed, triggered by the pandemic and the time for resorting to a hit or miss approach, is now virtually over. From pharma marketers’ point of interest, it will now be at one’s own peril for not challenging the pre-Covid business traditions, rules, and well-tried strategies on customer relationships and brand building models. This brings us to the question on what specifically have changed in the new normal as the pharma industry navigates thorough the Covid pandemic – for close to two years now.  

Pandemic-triggered changes in the pharma marketing area:

Changes are many and are being studied across the world. One such recent analysis, articulating how the pandemic triggered changes have redefined marketing, was published by the Harvard Business Review (HBR), on March 10, 2021. This paper came more than a year after the pandemic overwhelmed the world. This article listed some interesting macro-level changes, including the following:

  • Old normal: You are competing with your competitors.
  • New normal: You are competing with the last best experience your customer had.
  • Old normal: Customers hope you have what they want.
  • New normall: Customers expect you to have exactly what they want.
  • Old normal: Courting customers is just like dating.
  • New normal: Courting customers is just like online dating.
  • Old normal: Customers must sit at the heart of your marketing strategy.
  • New normal: Customers must sit at the heart of your customer journey.
  • Old normal: Agility is a technology process.
  • New normal: Agility is a modern marketing approach.
  • Old normal: Your brand should stand behind great products.
  • New normal: Your brand should stand behind great values.

To illustrate the point, let me now give a few examples of some micro-level changes in the same space.

Some transformation trends:

I am citing a few examples related to pharma’s traditional sales and marketing models. One such area is, quite a few companies are adopting connected data based and analytics-supported Omnichannel approach for customer engagement. The key objective is to deliver coherent and high-quality customer experience.

The need for new commercial models for the changing life sciences market, was also highlighted in an interesting article, published in the Pharmaceutical Executive on September 16, 2021. The authors identified six health care macro trends, demonstrating the value of transforming care delivery and shifting market behavior that prompt to reframe customer value propositions.

Taking a cue from this paper, I am listing below some of the current trends – as I see these and wrote before in this blog. Each one of these calls for well-connected data with analytics support:

  • Fostering a new genre of ‘customer-brand relationship’ to drive more targeted go‑to‑market strategies, enhanced agility/mobility of resources and highly personalized customer interactions.
  • Meeting the growing demand for value‑based care with novel risk‑adjusted and outcome‑based Price-Value-Models, supported by ongoing innovation in this area and sophisticated approach to value, affordability and outcomes.

Interestingly, despite Herculean constraints, many pharma players continued creating and delivering value, as the customers were expecting with changing situations.  

Drug-price sensitivity is increasing:

In the new normal, drug price sensitivity of customers is increasing manifold, for various reasons. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India.

In my article of September 14, 2020, I also wrote that the concept of ‘fair pricing a drug’ is being deliberated by many experts around the world, since quite some time, till today. But it continues. Most recently, as reported on September 22, 2021, for different reasons related to its new Alzheimer’s drug - Aduhelm, including its hefty price tag of $56,000 annually per patient, ‘Biogen reps banned from D.C.-area neurology clinics.’

Regardless of such customer reactions, the pharma industry, as reported on September 17, 2021, continues to advocate – drug pricing pressure will stifle innovation, blocking patient access to needed medicines and dry up investment in important R&D on new therapies. Curiously, the Pharmaceutical Research and Manufacturers of America (PhRMA), is spending more than $1 million on TV ads as part of a massive lobbying and communications campaign emphasizing the potential harm to patients seeking cures for deadly diseases, as the report highlights.

Innovation – remained mostly unhindered from old to new normal:

Customers’ expectations can’t be ignored indefinitely. Interestingly, the world has also witnessed it with Covid drug and vaccine innovation continuing even during the most trying times during the pandemic, even in India. It is, therefore, quite understandable why unfettered access to drug innovation is considered an oxymoron, by many.

The good news is, despite shrill voices over pricing measures, the quest for adding meaningful value to the healthcare space continues unhindered. As reported on September 19, 2021, both Pfizer and Merck are advancing oral antiviral candidates targeting Covid-19 into late-stage testing. Thus, I reckon, regardless of jarring noise from pharma lobbyists, drug innovation, willy-nilly, has to satisfy the diverse demand of health care customers.

Innovation needs to satisfy demands of diverse healthcare customers:

That, increasingly, drug innovations will need to be based on their ability to satisfy the demands of life sciences companies’ diverse customer-perceived value-based, was also echoed by the Pharmaceutical Executive article of September 16, 2021.

While doing so, companies will need to structure innovation in terms of health outcomes, affordability, and personalization, as the paper emphasized. It further added, ‘broader definition of innovation means products are no longer the central driver of value.’ Instead, innovation will be powered by an increasingly diverse stream of data that resides outside the confines of the traditional health ecosystem.

Covid pandemic accelerated the transition of this process of innovation, drawing its new focus on providing a seamless and holistic customer experience in the disease treatment process – supported by advanced analytics and this deeper understanding of customer segments.

Conclusion:

Many pharma marketers have possibly undertaken a sophisticated and credible market scanning exercise in the new normal, to assess by themselves what have or haven’t changed in their customer preferences and market dynamics. If not, I would encourage them to initiate it, at least, now.

Equally noteworthy, as the above HBR article wrote, in the post pandemic period: ‘Beyond geography, marketing messages need to be personally relevant, aligned to an individual’s situation and values, as opposed to demographics, such as age and gender.’

The objective is to create a personal connection between the customer and the brand promotional content, aiming to influence the prescribing and purchasing behavior, based on their psychographic to attitudinal characteristics. This process would require creating and screening lots of customized data, supported by sophisticated analytics.

From the above perspective, I reckon, deep insight on what have or haven’t changed in the healthcare environment alongside its customers, would be of fundamental importance for pharma marketers, in the new normal.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Unfettered ‘Access To Drug Innovation’ – An Oxymoron?

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The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, supposedly, depends on the speed of Covid-19 vaccination, the drug industry’s public reputation in the interim period, driven by its rapid response to the crisis, got an unsurprising boost (62%). This was captured by the Harris Poll, released on March 15, 2021.

Interestingly, soon after the high of 62% approval rating, the decline began. It came down to 60% in May and then 56% in June 2021—and now down three more percentage points, according to the Harris Polls that followed. No wonder, why the FiercePharma article of August 24, 2021, carried a caption: ’Pharma’s reputation drops again. Could it foreshadow a return to the bottom?’

Further, in the new normal, especially when customer expectations and requirements from drug companies have significantly changed, MNC Pharma industry still appears to be in the old normal mode in this space. It still, reportedly, ‘believes that the need for innovation must be balanced with the necessity for more accessible medicines, within a robust IP and regulatory environment,’ in India.

The hidden purpose of the same could possibly be, as several industry watchers believe – availing benefits of greater access to one kind innovation, making access to other kind of innovation more difficult. Consequently, two critical points are reemerging, even in the new normal, as follows:

  • Aren’t Indian IP and regulatory ecosystems still conducive enough for MNC pharma players’ access to drug innovation?
  • In the name of greater access to pharma product innovation, are they creating barriers to pharma process innovation, delaying market access to complex generics and Biosimilar drugs – besides systematically eroding consumer confidence on such products?

In this article, under the above backdrop, I shall try to explore why the epithet – ‘access to drug innovation’ is considered an oxymoron – with contemporary examples from around the word, including India.

Aren’t Indian IP and regulatory ecosystems conducive to drug innovation? 

This allegation doesn’t seem to hold much water, as several successful local initiatives in Covid-19 vaccine development will confirm the same. Besides, already marketed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Zydus Cadila’s ZyCov-D, there are several others waiting in the wings. These include domestic drug makers like, Hyderabad based Biological-E, Bengaluru-based medical pharma startup’s – Mynvax, and Pune-based Gennova Biopharmaceutical’s m-RNA vaccine candidates. However, only critical difference is – Indian made Covid vaccines are more affordable and accessible to patients, as against those manufactured by MNCs, such as, Pfizer, Moderna and J&J.

If we look back to the old normal, one will also find similar instances of new drug discovery in India, which deliberated in my article of September 02, 2013. Let me give just a couple of examples below:

  • Ranbaxy developed and launched its first homegrown ‘New Drug’ for malaria - Synriam, on April 25, 2012
  • Zydus Cadila announced in June 2013 that the company is ready for launch in India its first New Chemical Entity (NCE) for the treatment of diabetic dyslipidemia –Lipaglyn.

Hence, meager wherewithal for R&D notwithstanding, as compared to the MNCs, Indian pharma players don’t seem to find the country’s IP and regulatory ecosystems not conducive to innovation of affordable new drugs with wider patient access.

Off-patent drugs also involve another type of major innovation:

Discovering an NCE is, unquestionably, a product of drug innovation. Similarly, developing a new – cost-effective, non-infringing manufacturing process to market off-patent drugs, like biosimilars, also involve another type of major innovation. Intriguingly, when the MNC pharma industry talks about ‘access to innovation’, the latter type of innovation isn’t publicly acknowledged and included in their drug innovation spectrum. This practice, reportedly, remains unchanged in their advocacy campaign, even in the new normal.

However, the fact is, the manufacturers of off-patent drugs, such as biosimilars, also need to follow a major innovative process, for which they require access to innovation. This was also captured in an editorial of the newsletter – Biosimilar Development. The deliberation addressed the question - Do biosimilars fit into the innovation paradigm? The editor began by articulating – hardly anyone publicly argues that the development of new manufacturing process of Biosimilar drugs is not an innovation. The industry can’t call them as a copy of an existing innovation, either.

This is also vindicated in the Amgen paper, published on February 11, 2018. It acknowledges, “Unlike small molecule generic drugs, biosimilars are not identical to the reference biologic or to other approved biosimilars of the same reference biologic, because they are developed using different cell lines and undergo different manufacturing and purification processes.” Moreover, biosimilars also carry a different International Nonproprietary Name (INN), because of their molecular differences from the reference drug. This has been specified in the nonproprietary naming Guidance document of the US-FDA of January 2017.

From this perspective, the next question that logically follows: Is process innovation as important as product innovation?

Is process innovation as critical a capability as product innovation?

This question was unambiguously answered by a pharma industry-centric Harvard Business Review(HBR) article – ‘The New Logic of High-Tech R&D’, published in its September–October 1995, issue. The paper emphasized, for the commercial success of a product ‘manufacturing-process innovation is becoming an increasingly critical capability for product innovation.’

When to meet patient-needs ‘access to innovation’ an oxymoron: 

‘Access to innovation’ is an interesting epithet that is often used by many drug companies for meeting unmet needs of patients. However, the same is also often used to create barriers to meeting unmet needs of more patients with cheaper biologic drugs, like Biosimilars, immediately after their basic patent expiry. This is mostly practiced by creating a patent thicket. Hence, drug companies’ advocacy for greater access to innovation is an oxymoron to many.

The same was echoed in another article – ‘How originator companies delay generic medicines,’ published by GaBI. It wrote, such practices delay generic entry and lead to healthcare systems and consumers paying more than they would otherwise have done for medicines. These include the following:

  • Strategic patenting
  • Patent litigation
  • Patent settlements
  • Interventions before national regulatory authorities
  • Lifecycle strategies for follow-on products.

A very recent piece on the subject, published by Fierce Pharma on August 31, 2021, vindicates that the patent life extension through the patent thicket is happening on the ground – denying patients access to cheaper equivalent, especially of off-patent biologic drugs within a reasonable time period. It highlighted:

  • The exclusivity of AbbVie’s Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year was extended by 130 patents.
  • The same company has applied for 165 patents for its another blockbuster Imbruvica. Launched in 2013, Imbruvica has already generated sales of $5.3 billion for AbbVie.

No wonder, why in February 2021, during a Senate Finance Committee hearing, Sen. John Cornyn blasted the company saying:

“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point, that patent has to end, that the exclusivity has to end, to be able to get it at a much cheaper cost.”

More reports are also available on attempts to erode consumer confidence in Biosimilar drugs, as compared to the originals.

Work for innovation sans eroding consumer confidence in Biosimilars: 

Making affordable new drugs and vaccines available to patients with ‘access to innovation’, deserves inspiration from all concerned. Curiously, even in the new normal, some big companies continue trying to erode consumer confidence in off-patent drugs, especially Biosimilars and complex generics.

For example, an article on Biosimilars moving to the center stage, published in the Pharmaceutical Executive on August 12, 2021, quoted an interesting development in this space. The article highlighted that US legislators are now ‘eyeing measures to deter innovator promotional messages that disparage follow-on competitors.’ This initiative was spurred by US-FDA criticism of an Amgen promotional communication for undermining consumer confidence in Biosimilars to its Neulasta (pegfilgrastim) injection.

On July 14, 2021, US-FDA’s Office of Prescription Drug Promotion (OPDP) sent a letter to Amgen carrying a caption ‘FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or  misleading promotional communication about its product’s benefit.

The letter, as reported in the above article, criticized the company for making a false claim of greater adverse events with the injection system used by Biosimilars compared to the Amgen product. OPDP advised Amgen and other firms to “carefully evaluate the information presented in promotional materials for reference products, or Biosimilar products” to ensure correct product identification and avoid consumer confusion.

Conclusion:

When the point is, creating a conducive ecosystem to promote access to innovation, it should be patient-centric – always, and, more so in the new normal, considering changing needs and expectations of health care customers.

The innovation of usually pricey new molecular entities, no doubt, meets unmet needs of those who can afford these. Whereas, manufacturing process innovation expands access to the same molecule, particularly when they go off-patent, by making them affordable to a vast majority of the population.

But powerful industry lobby groups continue pressing harder for unfettered ‘access to innovation’ with greater relaxation of the IP and regulatory framework of countries, like India. The situation prompts striking a right balance between encouraging more profit by helping to extend patent exclusivity and encouraging greater access to off-patent cheaper Biosimilars as soon as the basic patent expires.

The bottom-line is, both need to be actively encouraged, even if it requires new laws to discourage practices like, creating patent thickets or undermining the use of generics or Biosimilars, and the likes. The good news is lawmakers have started deliberating on this issue – along with increasing public awareness, which gets reflected in the pharma industry’s current reputation ratings.

Left unresolved soon, such piggyback ride on ‘access to drug innovation’ bandwagon to serve self-serving interests, would continue denying speedy entry of cheaper Biosimilars. From this perspective, it isn’t difficult to fathom, why unfettered access to drug innovation is considered an oxymoron, by many.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Setting A Cost Of Time That Patients May Gain From A New Therapy

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Since quite some, an intense ongoing debate about setting a cost of time, often by a few months, that patients could possibly gain from a new therapy for complex diseases. The answer still remains elusive.  Meanwhile, newer therapies for treating cancer, such as, Kymriah, priced at US$ 475,000, alongside several rare diseases, hit the market with jaw-dropping prices. The latest being - Zolgensma of Novartis, carrying a price tag of US$ 2.12 million – the most expensive treatment ever. This trend assumes greater significance as Bio – claimed as the world’s largest trade association representing biotechnology companies, and related organizations, across the United States and in more than 30 other nations, also makes some interesting points in this area.

This article will dwell on the relevance of this important issue, both in today’s and also in the future perspective. It will try to explore, why pharma and biotech companies are not keen to use a ‘transparent multi-factorial life-value calculator’, especially for prolonging life or curing an incurable disease, with a high-priced novel therapy.

Emotional ads to justify the trend, against tough practical questions: 

A part of a sleek looking advertisement from Bio, depicting the power of new therapies to prolong life, carries a headline – ‘Time. The Currency of Life,” followed by three emotive lines and two equally emotive questions: “Another decade with a spouse. A few more years with your best friend. A rich, fuller life rather than one cut short. How do we place value on these?” It then asks: “What is more precious? What is more priceless?”

Turning this emotive question on its head to a rational one, an article published in the Stat News on February 25, 2016 questioned: “How much is an extra month of life worth?” It asked the drug makers to calculate the same. The same article also quoted a Yale University economist and practicing radiologist asking: “It’s all well and good to just say life is priceless, but the reality is we are paying for it.”

Emotive ads try to justify funding towards innovation for such drugs:

The same advertisement, as above, while trying to indirectly justify such exorbitant drug costs, used yet another emotive note in its playbook. It emphasized: “By continuing to fund the innovation pipeline that has served us so well, we will be able to reduce the costs associated with modern-day health care.”

Such claims are being scientifically challenged – head on, by many important studies. To illustrate this point, I shall quote the following two, both were published in the JAMA Network. The first one in the JAMA Otolaryngology-Head & Neck Surgery and the next one in JAMA Oncology.

The first article is the ‘John Conley Lecture’, carrying a title, ‘Unintended Consequences of Expensive Cancer Therapeutics—The Pursuit of Marginal Indications and a Me-Too Mentality That Stifles Innovation and Creativity,’ appeared on December 2014. On innovative drugs of such genre, the paper concluded: “The use of expensive therapies with marginal benefits for their approved indications and for unproven indications is contributing to the rising cost of cancer care. We believe that expensive therapies are stifling progress, by:

  • Encouraging enormous expenditures of time, money, and resources on marginal therapeutic indications and
  • Promoting a me-too mentality that is stifling innovation and creativity.

The second article is an ‘original investigation, titled ‘Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated with New Cancer Medicines.’ It also underscored: ‘Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.’

Here again, the emotional appeal is being made by creating a ‘perfect World’ scenario. Whereas, scientific analysis of the innovative and high-priced drugs, reveals the reality for other stakeholders to take note of. Different pharma trade associations, although being a part of the same orchestrated effort, try differently to take the eyes off the humongous prices of new life-saving drugs. But many continue to believe that new cancer drug prices have long gone beyond control.

90 percent Biopharma companies do not earn a profit – A bizarre claim?

As is well-known, besides justifying high drug prices by highlighting ‘high R&D cost,’ drug manufacturers often say, as the Bio ad campaign makes an eyebrow raising claim – “Of the approximately 1,200 Biopharma companies in the United States, more than 90 percent do not earn a profit.”

Citing the example of the US market where drug prices are very high, it justifies, the general focus on list prices of the drugs is misplaced. This is because, the ‘manufacturers provide billions of dollars in rebates and discounts on their innovative therapies annually, to federal, state and private payors, in addition to offering direct assistance through patient assistance programs.’ It further added, these discounts vary but can result into a significant total of as much as 50 percent or greater depending on the program.

Experts have challenged even this claim that the list prices do matter, even in the US, for many, including uninsured population and those with co-payment arrangement, which are not based on the discounted prices. Leaving aside America, what happens in those countries, such as India, where out-of-pocket expenses on health care are considered the highest in the world?

With new cancer drug prices going beyond control, the price of postponing death is growing:

That the new cancer drug prices have long gone beyond control, isn’t a new realization. A research paper, published in the Journal of Clinical Oncology on May 06, 2013, also noted emphatically: ‘Allowing the producer-dominated market to set drug prices has spiraled the cost of cancer drugs out of control.’  So did another 2015 study, published in the Journal of Economic Perspective.

According to various studies, such as the one published in the JAMA Otolaryngology-Head & Neck Surgery, as quoted above, also found after studying over 70 of such new drugs that the median improvement in survival was around 2.1months. Some other reports indicated this number to be around 3.5 months on an average.

Interestingly, the 2015 study, published in the Journal of Economic Perspective found that ‘the price of postponing death is growing. In 2013, one extra year of life for cancer patients costs US$ 207,000, on average, nearly quadruple what it did in 1995.

Is it quality of life over the quantity of life, or vice versa?

The above findings may lead one to the critical question – what type of treatment choice would create the most desirable net impact on individual cancer patients? This evaluation should include all the three parameters – the extent of prolongation of the ‘Length of Life (LoL)’, the ‘Quality of Life (QoL)’ the patients experience during this period – and the additional drug cost that needs to be incurred.

It should ideally be up to patients whether they will choose quality over quantity of life or vice versa. To facilitate this process, an informed briefing by the doctor on the most likely scenario, vis-à-vis other available treatment alternatives, is expected to help individual cancer patient exercise the best affordable individual option.

This point was scientifically addressed in a research article - ‘Quality of life versus length of life considerations in cancer patients: A systematic literature review,’ published in the Journal of Psycho-Oncology on May 15, 2019. The study noted, ‘Patients with cancer face difficult decisions regarding treatment and also the possibility of trading the Quality of Life (QoL) for Length of Life (LoL).’ Little information is available on patients’ preferences in this regard, including ‘the personal costs they are prepared to exchange to extend their life.’

Another related question that also remains equally elusive, is the relationship between the cost of a medication and the amount of quality-time that it offers to patients. Quantifiable assessment of such nature could bring more transparency in drug pricing, especially for those that help treat life-threatening ailments, such as cancer.

Similar questions are raised on pricey therapy for rare diseases:

The cost of drugs for rare diseases is threatening the health care system – articulated an article, published in the Harvard Business Review (HBR) on April 07, 2017. The paper stated, in December 2016, US-FDA announced the market approval of nusinersen (sold as “Spinraza”), an effective Spinal Muscular Atrophy (SMA) treatment licensed to Biogen by Ionis Pharmaceuticals. SMA is considered the most common genetic cause of infant mortality.

As the author penned, “Patients and providers greeted the approval with near ecstasy, but the celebration was bittersweet. Five days after the FDA approved, the drug, Biogen announced each dose would cost US$ 125,000. Given that patients need six doses in the first year and three per year after that, it means the drug costs US$ 750,000 per patient in the first year and US$ 375,000 annually thereafter.”

A desperate father’s reaction for the price – and the economics behind it:

The HBR article captured the reaction of the father of an infant on this price, who is desperate to save the baby – in the following words – “Then there’s Will’s heartbreaking reaction, which I’m sure echoes the sentiments of many touched by SMA. – “The Biogen announcement of the cost of nusinersen floored me in every way possible,” he says. “Words cannot describe the sickening feeling I get when I think about it.” If this could be a father’s reaction in America, one can well imagine what happens in a similar situation to people in the developing world.

At that time, Zolgensma of Novartis, wearing a price tag of US$ 2.12 million for treatment of the same disease, was also shaping up for market launch. On this drug, the author of this HBR article who also happened to be a professor, vice chair of research, and chief of the Division of Neuromuscular Medicine at the University of Utah School of Medicine, wrote: “A very promising gene therapy for SMA is on the horizon, which would require only one dose and potentially render nusinersen obsolete. Did such mercenary economics influence Biogen’s pricing decision? We may never know; drug companies are not required to justify their prices.” On the contrary, as many believe, the concerned global CEOs, reportedly, get a hefty financial reward, for the same.

Conclusion:

It is not difficult to understand either, that some drugs, especially for rare diseases, will be used for treating a smaller number of patients. Hence, the optimal economies of scale in manufacturing can’t be attained. At the same time, the cost of R&D of the therapy needs to be recouped along with a reasonable profit, for investment towards future drugs. This is in addition to market exclusivity the drug will enjoy through patent thicket.

Nevertheless, despite the existence of several methods of a human life value calculation, such as in the insurance industry the use of a transparent and drug industry specific, multi-factorial live-value calculator is still not in vogue. As the drug industry often highlights, the ‘value of human life is priceless’ – regardless of the costs of drugs. In this situation, many industry experts, academics and patient groups advocate that the ongoing uncontrolled pricing mechanism for such medicines should be brought under a leash. This could come in the form of a tough price negotiation’ before the drug marketing approval, as was promised by the Government, or putting in place a stringent price regulatory system.

Be that as it may, the bottom line is to understand and find an answer to: ‘Why Does Medicine Cost So Much?’ This issue was analyzed by the Time Magazine in its April 09, 2019 edition. Quoting Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, it emphasized: It all starts with the manufacturers. There are essentially no regulations governing how new drugs are priced – drug companies select a price what they “believe the market will bear.” Blockbuster first-in-class treatments, therefore, command a stratospheric price, like what happened with Gilead’s hepatitis medication – Sovaldi, way back in 2013. It was priced at US$ 1,000 a pill, or US $84,000 for the full course of treatment. From this perspective, although, setting a cost of time that patients may gain from a new therapy has a moral and ethical relevance – but actually, it doesn’t seem to be business-friendly in the drug industry.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.